A Pilot Evaluation of the Effect of the Erchonia Verjú™ and EVRL Lasers on Reducing Aminoalanine Transaminase (ALT) in Individuals With Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Percent (%) change from Baseline to Subject Study Endpoint evaluation in aminoalanine transaminase (ALT) level.
研究概览
简要总结
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia VERJU and EVRL laser devices is effective in reducing aminoalanine transaminase (ALT) levels in individuals with nonalcoholic steatohepatitis (NASH).
详细描述
Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disorder in the USA, present in 20% to 30% of the population and rapidly increasing. Fatty liver is generally diagnosed by abdominal ultrasound frequently as an incidental finding. Major risk factors for NAFLD include central (or abdominal) obesity, diabetes, elevated lipids, and metabolic syndrome.
Nonalcoholic steatohepatitis (NASH) are those patients where the presence of fat in the liver is accompanied by an inflammatory process that can cause progressive fibrosis in the liver. Which can ultimately lead to end stage liver disease (i.e., cirrhosis) and hepatic failure requiring liver transplantation. The 1990's was the decade of hepatitis C-related cirrhosis requiring transplantation. NASH is found in 3-5% of the population and is a subset of those patients with fatty liver.
Aminoaminoalanine Transaminase (ALT) is the liver enzyme measured in the blood that is a surrogate marker for inflammation and is frequently elevated in patients with NASH. Normalization of ALT is the ultimate treatment goal; however reduction in ALT is of significant clinical benefit.
Currently, the only treatment modality for patients with fatty liver disease is weight loss and exercise which is challenging for most patients. Therefore, a huge need exists for an alternative approach to reducing ALT levels for these patients.
Low level laser light therapy (LLLT) offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving this goal, through LLLT's proven ability to effect weight loss, body circumference reduction and inflammation reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Review of subject's pre-existing medical records to confirm the current diagnosis of nonalcoholic steatohepatitis (NASH) according to the following criteria:
- •ALT elevated on two separate determinations
- •Abdominal ultrasound showing fatty liver
- •Blood work that excludes other potential etiologies of liver disease
- •Subject has been on a stable diet and exercise regimen for NASH within the prior 6 months
- •Subject agrees to maintain his or her current diet and exercise regimen throughout study participation
- •Subject agrees to abstain from participating in any new treatments for NASH, other than the study treatments, throughout the course of study participation
- •Elevated aminoalanine transaminase (ALT) level, defined as 20 or more Unites/Liter (U/L) above the normal gender-specific ALT levels: males: ALT ≥ 60 U/L; females: ALT ≥ 50 U/L
排除标准
- •History of cardiovascular disease or events including, but not limited to, coronary artery disease, valvular heart disease, cardiac arrhythmias, congestive heart failure, myocardial infarction, stroke, transient ischemic attack, or peripheral vascular disease
- •Cardiac surgeries or procedures, including but not limited to, coronary artery bypass surgery or stent placement, heart transplantation, pacemaker insertion or implantation of a defibrillator
- •An implanted device in the target area to receive low level laser light therapy (e.g. pain pump, lap band, penile inflation device, ventriculo-peritoneal shunts, etc.)
- •Known photosensitivity disorder
- •Current active cancer or within one year of cancer treatment or remission
- •Excessive alcohol consumption defined as 14 or more alcoholic drinks per week
- •Pregnant, breastfeeding, or planning pregnancy prior to the end of study participation
- •Serious mental health illness that in the opinion of the investigator would preclude the subject from study participation
- •Active infection, wound or other external trauma to the target area to receive the laser therapy
- •Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements
- •Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to NASH
- •Participation in a clinical study or other type of research in the past 30 days
结局指标
主要结局
Percent (%) change from Baseline to Subject Study Endpoint evaluation in aminoalanine transaminase (ALT) level.
时间窗: 2 or 3 months
次要结局
未报告次要终点